FDA approves two new long-acting insulin products

The U.S. Food and Drug Administration (FDA) and Novo Nordisk on Sept. 25 announced the approval of two products containing the long-acting human basal insulin and analog insulin degludec, to improve blood glucose control in adults with type 1 or 2 diabetes.

"Long-acting insulins play an essential role in the treatment of patients with type-1 diabetes and in patients with type-2 diabetes with advanced disease," Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said. “The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”

Insulin degludec is a recombinant analog of human insulin with one amino acid deletion and an added side chain consisting of glutamic acid and a fatty acid.

Novo Nordisk said Tresiba, or insulin degludec injection, will be available during the first quarter of 2016. The product is indicated for use as monotherapy or in combination with oral antidiabetic agents or mealtime insulin products.

Novo Nordisk has not announced a launch date for the second product, Ryzodeg, which contains a 70/30 mixture of insulin degludec and insulin aspart.

According to the FDA, the most frequently reported adverse side effects associated from the use of Tresiba or Ryzodeg during clinical trials were hypoglycemia, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, edema and weight gain.